Low Dose Radiotherapy for Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Low Dose Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Osteoarthitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Study of Low Dose Radiotherapy for Osteoarthritis
Overview
This single institution, multi-site, single arm prospective study will enroll patients with a history of OA and assess changes in pain and function after treatment with LDRT as measured by patient-reported outcomes.
Detailed description
To evaluate the use of select instruments (BPI-SF, LEFS, UEFI, PROMIS Global) to detect changes in pain, function, and well-being in patients with OA who are refractory to or otherwise unable to receive other standard of care therapies.
Interventions
- Radiation Low Dose Radiation Therapy
Participants will complete study intervention which consists of the BPI-SF, PROMIS Global v1.2, UEFI (for those with joint pain of the upper extremity) and/or LEFS (for those joint pain of the lower extremity) at baseline, 3-month and 1-year follow-up following 1 or 2 courses of standard of care LDRT.
Primary outcome measures
- To measure the percentage of subjects who experience a best response of 1 point or more on BPI-SF [Time frame: Within 1 year]
Secondary outcome measures (4)
- To measure the percentage of subjects who experience a best response of 1 point or more on BPI-SF [Time frame: at ~ 3 months]
- To measure change in PROMIS scores [Time frame: From baseline at 3-month and 1-year follow-up]
- To measure change in LEFS scores as measured [Time frame: From baseline at 3-month and 1-year follow-up]
- To measure change in UEFI scores as measured [Time frame: From baseline at 3-month and 1-year follow-up]
Eligibility criteria
Inclusion criteria
- 18 years or older
- Diagnosis of OA >3 months in hips, knees, hands, shoulders, ankles or elbows.
- Refractory to standard of care therapies for OA or those who are being considered for more aggressive interventional treatment such as joint replacement, but more conservative treatment is desired.
- Provision of signed and dated informed consent.
Exclusion criteria
- Unable to reasonably complete study instruments.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Penn Presbyterian Medical Center — Philadelphia
- Perelman Center for Advanced Medicine — Philadelphia
Identifiers
NCT: NCT07715188 · UPCC 02025